Delhi’s All India Institute of Medical Sciences (AIIMS) will submit a proposal to the Institute of Ethics Committee to seek permission to begin the Phase 3 clinical trials of Bharat Biotech’s coronavirus vaccine, Covaxin, in the coming week.
Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi, said, “The proposal is being prepared for the Phase 3 trials and, within a couple of days’ we will be submitting it to the institute of the ethics committee for approval.”
AIIMS Delhi is selected for the final-stage of COVID=19 vaccine trials and the institute plan of recruiting 2000 – 5000 participants. As per the rules of the Indian Council of Medical Research (ICMR), an ethics committee needs to oversee all of the clinical research. They also need to review the proposal before allowing the trial to go-ahead. Bharat Biotech had received a nod for Phase 3 trials on October 22.
AIIMS ethics committee may take up to 14 days for granting the approvals. The Indian Institute of Medical Sciences (IMS), SUM hospital and Odisha are getting prepared to set up the third phase of human trials for COVID-19 vaccine.
Dr E Venkata Rao, Principal Investigator in the Covaxin human trial and a professor in the Department of Community Medicine at IMS and SUM Hospital said, “The Central Drugs Standard Control Organisation (CDSCO) has approved for the third phase trials of Covaxin.”
On October 2, Bharat Biotech asked permission from DCGI to conduct a Phase 3 randomized double-blind placebo-controlled multicentre trial of Covaxin. The study would include more than 28,500 participants, who will be above the age of 18 years and it will be conducted in 10 states at 19 sites.
The Hyderabad-based firm, Bharat Biotech was in collaboration with ICMR and the National Institute of Virology while developing a vaccine against COVID-19. Two doses of the Covaxin will be given in a gap of 14 days.
